Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031093388

FEI Number

3031093388

Entity Name

DENTIUM CO.,LTD(ICT BRANCH)

City/State/Country

Yongin Gyeonggi, KR

Establishment Address

(16985) 150, Eondong-ro, Giheung-gu, Yongin-si, Gyeonggi-do, Yongin Gyeonggi 16985, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dentium Co.,Ltd(ICT branch) (Owner Number: 10076095)

Owner / Operator Contact Address

(16229) 76, Changnyong-daero 256beon-gil, Yeongtong-gu, Suwon, KR-41 16229, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200270

PMA Number

N/A

All Registered Proprietary Names

rainbow CT iCTmotor bright CT bright MCT rainbow MCT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2021-04-19
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2020-09-06
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2023-12-19
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2021-04-19

Official Correspondent

Hyojeong Lee

US Agent Details

EUNKYUNG SON Email: json@dentiumusa.com Phone: (714) 2260229

Related Public Records

Same Entity

Dentium Co.,Ltd(ICT branch)

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3017403245	DENTIUM CO.,LTD(ICT BRANCH)	Suwon Gyeonggi, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K040153	Indigenous Peoples Technology and Education Center	I-TEC PORTABLE DENTAL OPERATORY	2004-05-21

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3004706313	VATECH CO., LTD.	Hwaseong-si Gyeonggi, KR
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031093388. Last updated year: 2026. Please use registration number 3031093388 when referencing this establishment in official correspondence.